Gillian M. Duchesne, MD
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy (ADT) was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of life. The findings were reported by Gillian M. Duchesne, MD, of Peter MacCallum Cancer Centre, and colleagues in The Lancet Oncology. This study has shown that immediate androgen-deprivation therapy was associated with improved overall survival vs delayed androgen-deprivation therapy.
In the open-label trial, 293 men with prostate-specific antigen– only relapse after definitive treatment or de novo noncurable disease from 29 sites in Australia, New Zealand, and Canada were randomized between September 2004 and July 2012 to receive immediate androgen-deprivation therapy (n = 142) or delayed androgen-deprivation therapy (n = 151). Any type of androgen-deprivation therapy and intermittent and continuous schedules were permitted.
European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaires QLQ-C30 and PR25 were completed at baseline, at every 6 months for 2 years, and annually for 3 years. Analysis was by intention to treat, with statistical significance set at P = .0036.
Health-Related Quality of Life
No differences between the two groups were observed for global health–related quality of life over 2 years or for global quality of life, physical functioning, role functioning, emotional functioning, fatigue, dyspnea, insomnia, or feeling less masculine over 5 years. Sexual activity was poorer in the immediate androgen-deprivation therapy group at 6 (P < .0001) and 12 months (P < .0001), with differences exceeding the threshold for clinical significance (10 points) for > 2 years.
The immediate androgen-deprivation therapy group had more hormone treatment–related symptoms at 6 (P < .0001) and 12 months (P < .0001), with differences not reaching the threshold of clinical significance. Among individual symptoms, adjusted proportions of patients with clinically significant hot flushes (0.55 vs 0.31, adjusted odds ratio [OR] = 2.87, P < .0001) and nipple or breast symptoms (0.14 vs 0.06, adjusted OR = 2.64, P = .00013) were higher among immediate androgen-deprivation therapy patients over 5 years.
The investigators concluded: “Immediate use of androgen-deprivation therapy was associated with early detriments in specific hormone-treatment-related symptoms, but with no other demonstrable effect on overall functioning or health-related quality of life. This evidence can be used to help decision making about treatment initiation for men at this disease stage.”
The study was funded by the Australian National Health and Medical Research Council and Cancer Councils, The Royal Australian and New Zealand College of Radiologists, Mayne Pharma Australia, and Tolmar Australia.